K251382
- 510(k) number
- K251382
- Device name
- Phoenix Sinus Tarsi Stent System
- Applicant
- Astra Orthomed, Inc. TN · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-08-27
- Date received
- 2025-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251382.pdf
Official FDA record: K251382
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.